MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT; ARTHROSCOPE

Catalog Number UNK_END

Device Problem Poor Quality Image (1408)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.The gtin and 510(k) number are unknown at this time, as the reported device is unknown.However, should it become available it will be provided in future reports.

Event Description

It was reported that there was a blurry image.

Manufacturer Narrative

The reported device was not received for investigation; therefore the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation.In the event that the device is received, the complaint will be reopened and the investigation will be updated with the new results.Alleged failure: all-blurred optics.Probable root cause: incorrectly assembled optical train; damage to optical train; end of life wear-out; shipping damage; use error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text: 81.

Event Description

It was reported that there was a blurry image.

• Brand Name: UNKNOWN_ENDOSCOPY_PRODUCT
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11467538
• MDR Text Key: 242083014
• Report Number: 0002936485-2021-00141
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNK_END
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1